Health officials at the U.S. Food and Drug Administration approved the latest version of Covid vaccines on Thursday ahead of the coming winter virus season.
The agency approved updated Covid vaccines manufactured by Moderna, Pfizer, and Sanofi after an advisory panel recommended that the new formulas target the XFG 'Stratus' variant.
XFG is a variant derived from the Omicron Covid virus that dominated last year's virus season. The variant has been associated with a particularly painful sore throat that patients describe as feeling like a 'razor-blade.'
Officials said the Moderna and Pfizer shots are expected to begin shipping to doctors' offices and pharmacies within the next several days. Sanofi, which distributes the non-mRNA shot Novavax, also known as Nuvaxovid, said doses will become available in the coming days, with timing varying by location. Unlike mRNA vaccines that instruct cells to produce viral proteins, Novavax is a protein subunit vaccine.
Eligibility and approval criteria
Similar to last year, the FDA approved the updated shots for Americans aged 65 and older. The approval also covers younger individuals who have an underlying health condition that increases their risk of severe illness from Covid, such as asthma, heart failure, and Chronic Obstructive Pulmonary Disease (COPD).
Approval age limits vary depending on the specific manufacturer. Moderna's vaccine is approved for children six months of age and older, while the Pfizer shot can be given to individuals over the age of five. Sanofi's shot is approved for people aged 12 and older.
People who are not formally eligible under the FDA approval criteria can still receive the vaccines, although some doctors and pharmacies may decline to administer them off label. Previously, the shots were available to all Americans aged six months and older. However, the Trump administration stopped routinely recommending Covid boosters for healthy younger adults and children last year, citing personal choice rather than necessity.
The FDA estimates that roughly 30 to 60 percent of Americans have a pre-existing health condition that would qualify them for a Covid vaccine under the current authorization guidelines.
Insurance coverage and state guidance
It remains unclear whether all private and public health insurance plans will cover the newly approved shots. The updated formulas are not currently recommended by the Advisory Committee on Immunization Practices (ACIP), the federal panel that sets official national vaccine guidelines for medical providers.
It also remains to be seen whether specific states will issue their own independent vaccine guidelines. Last year, the governors of several Democratic states, including California, Oregon, New York, New Jersey, and Connecticut, issued their own guidance for residents in their states.
In New York, Governor Kathy Hochul previously signed an executive order allowing licensed pharmacists across the state to prescribe and administer Covid vaccines directly to any New Yorkers who requested them.
Timing, peak season, and side effects
The winter virus season in the United States typically lasts from October through May, although health officials note it is unclear if there is a specific time during which it is best to get vaccinated. Dr William Schaffner, a professor and infectious disease specialist at Vanderbilt University Medical Center in Nashville, Tennessee, told The New York Times that October is the best time to receive the shot so that coverage lasts for the majority of the season. Protection against the virus tends to wane after a few months.
Although the Centers for Disease Control and Prevention (CDC) no longer strictly tracks total Covid cases, public health data from last season showed that hospitalizations peaked nationwide in January.
Health authorities note that typical side effects following a Covid vaccine injection remain mild. Common reactions reported after vaccination include a sore arm at the injection site, fever, muscle pain, and chills.
